Effect of a Natural Eye Drop, Made of Plantago Ovata Mucilage on Improvement of Dry Eye Symptoms: A Randomized, Double-blind Clinical Trial.

Abstract

Dry eye disease is a relatively common eye disorder associated with decrease in quality of life. In this study, efficacy of an eye drop of Plantago ovata mucilage on symptoms of dry eye disease was evaluated. In a randomized, double-blind, placebo-controlled clinical trial, sixty dry eye patients with ocular symptoms and total Ocular Surface Disease Index (OSDI) score of ≥12 were randomly assigned to receive either a natural ophthalmic drop, made of Plantago ovata mucilage or placebo 4 times a day for 6 weeks. The patients were evaluated at pretreatment (baseline), weeks 4 and 6 post-treatment. The evaluation of the efficacy and safety were conducted based on the OSDI questionnaire, the noninvasive tear film break-up time (NI-BUT) with keratograph, the Schirmer test without anesthesia, and the osmolarity test, as well as by monitoring possible adverse events. After 6 weeks, within group analysis showed a significant improvement in total OSDI score (p < 0.001). In addition, between group comparison revealed a significant improvement in the OSDI score of the intervention group (p < 0.001). Although, NI-BUT was significantly improved in the Plantago ovata group (p = 0.004), however no statistically significant difference was observed in between group analysis. There were no significant differences between two groups, or significant changes within the groups in the Schirmer test without anesthesia and the osmolarity test. No serious adverse events were reported. In conclusion, P. ovata mucilage is a natural, inexpensiveness, and safe lubricant polymer that could have beneficial ocular effects on subjective symptoms of the patients with dry eye disease.